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Clinical Trials/NCT04232150
NCT04232150
Completed
Not Applicable

Midazolam's Anterograde Amnesia Efficacy in Noisy Orthopedic Surgery: Does Midazolam Cause Effective Anterograde Amnesia in Noisy Orthopedic Surgeries?

University of Jordan1 site in 1 country116 target enrollmentJune 1, 2019

Overview

Phase
Not Applicable
Intervention
spinal anesthesia with no sedation.
Conditions
Anesthesia
Sponsor
University of Jordan
Enrollment
116
Locations
1
Primary Endpoint
Postoperative recall of auditory stimuli and intraoperative noise
Status
Completed
Last Updated
4 years ago

Overview

Brief Summary

Spinal anesthesia is one of the commonest choices of anesthesia for infraumbilical surgeries.The use of sedation has markedly increased patients' comfort and acceptance towards spinal anesthesia. The aim of this study is to investigate visual, recall, auditory recall, and sedation scores among patients receiving Midazolam for sedation during spinal anesthesia in patients undergoing orthopedic surgeries.

Detailed Description

Spinal anesthesia is one of the commonest choices of anesthesia for infraumbilical surgeries.The use of sedation has markedly increased patients' comfort and acceptance towards spinal anesthesia. The main goals of sedation for surgeries under spinal anesthesia are patient comfort, preservation of protective airway reflexes, and the help in the maintenance of hemodynamic stability during the surgical procedure. The aim of this study is to investigate visual, recall, auditory recall, and sedation scores among patients receiving Midazolam for sedation during spinal anesthesia in patients undergoing orthopedic surgeries.

Registry
clinicaltrials.gov
Start Date
June 1, 2019
End Date
November 1, 2019
Last Updated
4 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Mahmoud M. Almustafa

Principal Investigator

University of Jordan

Eligibility Criteria

Inclusion Criteria

  • patients undergoing total knee or total hip replacement.
  • ASA I, II, or III.
  • patients undergoing spinal anesthesia.

Exclusion Criteria

  • patient refusal.
  • \<24 hours sedative administration.
  • patient with hearing impairment.
  • neurological or memory disorder.
  • abnormal kidney function tests.
  • any contraindication for spinal anesthesia.

Arms & Interventions

Group C (control group)

control group will receive no sedation under spinal anesthesia.

Intervention: spinal anesthesia with no sedation.

Group O (single dose group)

patients will receive 0.025mg/kg midazolam sedation under spinal anesthesia.

Intervention: single-dose midazolam for sedation under spinal anesthesia.

Group M (double dose group)

patients will receive 0.025mg/kg midazolam sedation twice under spinal anesthesia.

Intervention: Double-dose midazolam for sedation under spinal anesthesia.

Outcomes

Primary Outcomes

Postoperative recall of auditory stimuli and intraoperative noise

Time Frame: 4 months

For auditory recall, a question was asked by the surgeon to the patient at maximum stimulation. Patients were examined for auditory recall by following-up the patients postoperatively in the inpatient department.

Postoperative recall of visual stimuli

Time Frame: 4 months

For visual recall, a picture of a horse assigned at maximum stimulation, a cat at recovery room, and a bird after discharge to the inpatient department. Patients were examined for visual recall by following-up the patients postoperatively in the inpatient department.

Study Sites (1)

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